Using milrinone to improve heart function in infants after PDA closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial aims to evaluate the effectiveness of milrinone in improving heart function in infants following patent ductus arteriosus (PDA) closure. Infants will be randomly assigned to receive either milrinone or a placebo saline solution shortly after the procedure. The study will monitor the infants closely for side effects and assess the drug's impact on survival rates and neurodevelopmental outcomes over a two-year period. The goal is to determine if milrinone can reduce the risk of death or post-ligation cardiac syndrome within a week of the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention
* Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
* Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
* Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.

Exclusion Criteria:

* Any major congenital malformation
* Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect)
* Acute renal failure defined by urine output \< 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
* Systemic administration of vasodilator/inodilator agents
* Prior history of arrhythmia

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Northwestern Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• University of New Mexico
  Albuquerque, New Mexico, United States Recruiting

Study contacts

• Study coordinator: Patrick J McNamara
• Email: patrick-mcnamara@uiowa.edu
• Phone: 319-467-7435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.